Safety and Effectiveness of an Anti-HIV Drug Combination in HIV-Positive Patients Who Have Failed Previous Treatment With Protease Inhibitors

The purpose of this study is to see if it is safe and effective to give an anti-HIV drug combination containing indinavir and ritonavir to HIV-positive patients who have failed previous treatment with protease inhibitors.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

LAC / USC Med Ctr / Infectious Diseases, Los Angeles, California, United States

About this study

Patients receive indinavir and ritonavir twice daily plus 2 NRTIs (NRTIs are not provided by this study). Physical examinations and laboratory tests, including plasma viral RNA levels and CD4 cell counts, are performed at Day 1 and Weeks 4, 8, 12, 16, 20, and 24 (or at discontinuation). The incidence of serious and drug-related adverse experiences is tabulated to determine drug safety. The proportion of patients achieving plasma viral RNA levels below 50 copies/ml (by UltraSensitive assay) are estimated statistically to determine drug efficacy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

You may be eligible for this study if you:

Are HIV-positive.
Have a viral load (level of HIV in the blood) of 2500 copies/ml or greater within 45 days of study entry.
Have a CD4 cell count of 100 cells/mm3 or greater within 45 days of study entry.
Have been on an anti-HIV drug regimen containing a protease inhibitor for at least 16 weeks and initially did well on this treatment (your viral load decreased significantly) but later experienced treatment failure on this drug combination (your viral load increased significantly).
Experienced treatment failure within 24 weeks of study entry.
Are 18 years of age or older.
Agree to use effective barrier methods of birth control (such as condoms) during the study.

Exclusion criteria

You will not be eligible for this study if you:

Are allergic to ritonavir or indinavir.
Have hepatitis.
Have an abnormal chest x-ray or abnormal liver function tests.
Have taken 2 protease inhibitors at the same time for 7 or more days.
Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) in the 2 weeks before study entry.
Have a medical condition that might make it unsafe for you to take the study drugs.
Have experienced resistance to NRTIs and no new NRTI therapy is possible.
Have taken certain medications.
Abuse alcohol or drugs.
Are pregnant or breast-feeding.

Treatment and study plan

Indinavir sulfate

Drug

Ritonavir

Drug

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Open-Label, 24-Week Study to Evaluate the Safety and Activity of Indinavir Sulfate 800 Mg b.i.d. in Combination With Ritonavir 200 Mg b.i.d. and Two NRTIs in HIV-1 Infected Patients Who Failed PI Therapy

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed